Clinical trial on the use of outdoor environment glasses

Not Applicable

• Conditions: Myopia in school children

• Registration Number: JPRN-jRCTs032180418
• Lead Sponsor: Hara Yutaka

Brief Summary

Because of the characteristic of the glasses in this research through which violet light can penetrate, the glasses take effect only in outdoor environments where violet light exists, and not in indoor where there is little violet light. Hence, the period of outdoor activities is an important factor, and therefore, the primary and the secondary endpoints did not reach significant statistical difference.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Study Completion: 2020-09-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

(1) Male and female school children between 6 and 12 years of age (elementary school 1st to 6th grade) at the time of obtaining informed consent
(2) School children who spend at least 1 hour every day outside
(3) School children with paralysis* of accommodation in both eyes where the objective spherical equivalent of each is between -1.50D and 4.50D
(4) School children with at least one parent who has myopia
(5) School children who can wear glasses daily and attend the clinic for consultations in accordance with the protocol
(6) School children who do not have eye diseases other than refractive error
(7) School children who have provided written informed consent themselves and written informed consent has been obtained from their parental authority for participation in this study

Exclusion Criteria

(1) School children with a history of wearing bifocal or progressive power lenses
(2) School children with a history of wearing orthokeratology lenses
(3) School children with unequal parallax exceeding 1.50D
(4) School children with astigmatism exceeding 1.50D
(5) School children with overt strabismus
(6) School children who have received refractive surgery in the past
(7) School children with keratoconus or herpes conjunctivitis, papillary proliferation, etc.
(8) School children who are participating in other similar clinical research
(9) School children who are judged to be inappropriate as subjects for this study by the principle investigator (or investigator) for the study (in charge)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in axial length between observation at baseline and observation after 24 months

Secondary Outcome Measures

Name	Time	Method
Change in objectively-measured spherical equivalent refraction between observation at baseline and observation after 24 months